AccessGUDID - DEVICE: Boekel Small Platelet Agitator (00863626000218)

GUDID

Device Identifier (DI) Information

Brand Name: Boekel Small Platelet Agitator
Version or Model: 301200
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 301200
Company Name: BOEKEL INDUSTRIES, INC.

Primary DI Number: 00863626000218
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002288215 *Terms of Use

Device Description: Device used to agitate platelets. May be used alone if temperature can be maintained to 22 degrees C +/- 2 degrees. may be used in conjunction with the Boekel Small Platelet Incubator.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45226	Platelet agitator	A mains electricity (AC-powered), electromechanical device typically used by blood bank and transfusion services to provide gentle agitation (e.g., side-to-side motion) required for platelet storage. The device will typically provide several drawers on which to place containers of platelets. It may include an audible alarm that sounds if agitation does not occur during use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KSQ	Device, Blood Mixing And Blood Weighing

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2fa7a85a-d7a6-4c4b-887d-ce5f7c9e7c56
Public Version Date: May 24, 2019
Public Version Number: 1
DI Record Publish Date: May 16, 2019